Postnatal Leaking, Exercise and Activity Shorts Evaluation (PLEASE) study
| ISRCTN | ISRCTN10972784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10972784 |
| Protocol serial number | N/A |
| Sponsor | Trinity College Dublin |
| Funder | Enterprise Ireland (UK) |
- Submission date
- 14/01/2015
- Registration date
- 05/02/2015
- Last edited
- 01/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In 2012, we started the MAMMI study to find out about the health and health problems experienced by first-time mothers during pregnancy and up to 1 year after their baby’s birth. According to the early results from this study, one in two women leak urine 3 months after their baby’s birth and one in five leak urine 6 months after their baby’s birth. Some women stop exercising because they leak urine and are concerned that the leakage will show on their outer clothing and be seen by others. The aim in the PLEASE study is to test two different kinds of sports shorts in women who leak urine.
Who can participate?
Women who leak urine while exercising
What does the study involve?
Women will be randomly allocated to either the intervention shorts or the other shorts group for 3 weeks. They will return their shorts and will be sent the other type of shorts to test similarly for a further 3 weeks. The shorts can be worn on their own or under track-suit bottoms or other sports clothes.
What are the possible benefits and risks of participating?
The benefits are feeling secure, comfortable and confident while exercising. Risks were not provided at the time of registration.
Where is the study run from?
Trinity College Dublin (UK)
When is the study starting and how long is it expected to run for?
From September 2014 to August 2015
Who is funding the study?
Enterprise Ireland (UK)
Who is the main contact?
Ms Deirdre Daly
dalyd8@tcd.ie
Contact information
Scientific
School of Nursing and Midwifery
Trinity College Dublin
24 D'Olier Street
Dublin
2
Ireland
| Phone | +353 1 8962604 |
|---|---|
| dalyd8@tcd.ie |
Scientific
School of Nursing and Midwifery
Trinity College Dublin
24 D'Olier Street
Dublin
2
Ireland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised double-blind cross over trial |
| Secondary study design | Randomised cross over trial |
| Scientific title | Postnatal Leaking, Exercise and Activity Shorts Evaluation (PLEASE): a randomised cross over study |
| Study acronym | PLEASE |
| Study objectives | Two different kinds of sports shorts will be tested to see if either, or both, help women who have postnatal urine leakage feel secure, comfortable and confident while exercising. 04/08/2015: Overall trial end date extended to 30/04/2016 from 31/08/2015. Additionally, the age range of participants at the time of recruitment has been changed from 3-6 month to 3-12 months. |
| Ethics approval(s) | Research Ethics Committee, Faculty of Health Sciences, Trinity College Dublin, 29/09/2014 |
| Health condition(s) or problem(s) studied | Urine leakage during exercising after giving birth |
| Intervention | 1. Women will be randomly allocated to either the intervention shorts or the other shorts group for 3 weeks. 2. At the end of the 3 weeks, women using the first type of shorts will be asked to document the exercise type and amounts and satisfaction with the product for that time using a standardised tested survey form. 3. Women will return their shorts and will be sent the other type of shorts to test similarly for a further 3 weeks. At the end of the second 3 weeks of using the second type of shorts, women will be asked to document the exercise type and amounts and satisfaction with the product for that time using the same standardised tested survey form. 4. Neither women nor researchers will be aware of which shorts have been sent until the coding is revealed at the end of the trial to avoid bias. 5. When women return the second pair of shorts, with their data, both pairs of shorts will be returned to them. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Measured with a standardised tested survey form at the end of 3 weeks: |
| Key secondary outcome measure(s) |
Measured with a standardised tested survey form at baseline: |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Taking part in the MAMMI (Maternal health And Maternal Morbidity in Ireland, http://www.mammi.ie/) study 2. Gave consent to being contacted about taking part in future research related to the MAMMI study 3. Not pregnant or planning a pregnancy during the study 4. Baby's age is between 3 months and 12 months at study start 5. Do at least 30 minutes of vigorous exercise twice a week and are willing to continue doing this amount of exercise for at least 2 months during the study |
| Key exclusion criteria | 1. Not taking part in the MAMMI study at the time of recruitment to the PLEASE study 2. Did not provide consent to take part in future research related to the MAMMI study 3. Pregnant or planning a pregnancy 4. Not exercising for at least 30 minutes, twice a week 5. Less than 3 months and more than 9 months postpartum 6. Ill |
| Date of first enrolment | 16/02/2015 |
| Date of final enrolment | 30/04/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
24 D'Olier Street
Dublin
2
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
